Peripheral Primitive Fibromatosis

Gustave Roussy, Cancer Campus, Grand Paris100 enrolled

Overview

It's a monitoring study. The aim is to assess the progression free survival up to 3 years. Patients are not treated until progression. Search for scalability predictive factors and registration of treatments if progression.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

100

Conditions

Peripheral Primitive Fibromatosis

Interventions

MRIOTHER

MRI every 3 months during the first year and then every 6 months during the second year and then one MRI up to 36 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Peripheral primitive fibromatosis * Adults patients * Peripheral primitive fibromatosis proved by biopsy * Peripheral primitive fibromatosis R2 resected for which monitoring is decided * MRI realized before inclusion * Patient information and informed consent signed Exclusion Criteria: * Local recur * Head and neck topography * Primitive fibromatosis R0 or R1 resected * Specific medical treatment of fibromatosis * Patient already included in an other clinical trial with an experimental molecule * Persons deprived of liberty * Impossibility to submit to the trial's medical follow-up for psychological, geographical or socials reasons * Previous history of cancer * Counter indication to the realization of an MRI

Locations (1)

Institut Gustave Roussy

Villejuif, Val de Marne, France

RECRUITING

Outcomes

Primary Outcomes

Progression Free Survival

Time frame: assessed up to 3 years

Secondary Outcomes

Functional result

Assessed with criteria for Adverse Effects-V4 scale once per year during the consultation

Time frame: 1 year

Data from ClinicalTrials.gov

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